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      Laboratory evaluation of four HIV/syphilis rapid diagnostic tests

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          Abstract

          Background

          Sexually transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries. HIV screening programmes have been widely used for many years. The introduction of rapid point-of-care tests (RDTs) that can detect both HIV and syphilis, using one single blood specimen, would be a promising tool to integrate the detection of syphilis into HIV programmes and so improve the accessibility of syphilis testing and treatment.

          Methods

          As part of the World Health Organization pre-qualification of in vitro diagnostics assessment, the laboratory performance of four dual HIV-Syphilis rapid diagnostic tests (SD Bioline HIV/Syphilis Duo, DPP HIV-Syphilis Assay, Multiplo Rapid TP/HIV Antibody Test and Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test) was assessed using a well characterized multiregional panel of stored sera specimens.

          Results

          In total 400 specimens were tested with each assay, resulting in excellent sensitivities and specificities for HIV, ranging from 99.5 to 100% and from 93.5 to 99.5%, respectively. Results obtained for the Treponema pallidum antibodies were lower, with the lowest sensitivity of 73.5% for Multiplo and the highest of 87% for SD Bioline. Specificities ranged from 99.0 to 100%.

          Conclusion

          Although these results suggest that the tests could further improve in accuracy in detection of treponemal antibodies, their introduction into screening programmes to increase the accessibility of HIV/Syphilis diagnosis and treatment for difficult to reach populations in the world is promising.

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          Most cited references22

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          Syphilis and HIV infection: an update.

          The striking increase in the prevalence of concordant human immunodeficiency virus (HIV) infection and syphilis observed by clinicians and public health officers over the past decade has renewed interest in the subject. Although the effect of HIV infection on the natural history of syphilis has been known for a long time, it was not until recently that several studies documented that syphilis may also impact the course of HIV infection. Despite an improved understanding of the interaction of these 2 conditions, many controversies still exist. In this article, we focus on the most recent literature describing the epidemiology, clinical manifestations, and treatment of syphilis in the context of HIV infection.
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            Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi.

            To determine the association between maternal syphilis and HIV mother-to-child transmission (MTCT). Prospective cohort study. Pregnant women admitted at Queen Elizabeth Central Hospital (Malawi) in late third trimester were screened for HIV (by HIV rapid tests) and syphilis (by rapid plasma regain test and Treponema pallidum hemagglutination assay). HIV-infected women and their infants received nevirapine, according to the HIVNET 012 protocol. They were followed up at 6 and 12 weeks postpartum. Infant HIV infection was diagnosed by DNA PCR. Of the 1155 HIV-infected women enrolled, 1147 had syphilis test results, of whom 92 (8.0%) were infected. Only 751 HIV-positive women delivered live singleton infants who were tested for HIV at birth. Of these, 65 (8.7%) were HIV-infected, suggesting in utero (IU) HIV MTCT. Of the 686 infants who were HIV-negative at birth, 507 were successfully followed up. Of these, 89 (17.6%) became HIV-infected, suggesting intrapartum/postpartum (IP/PP) HIV MTCT. Maternal syphilis was associated with IU HIV MTCT, after adjusting for maternal log10 HIV-1 viral load and low birth weight (LBW) [adjusted relative risk (ARR), 2.77; 95% CI, 1.40-5.46]. Furthermore, maternal syphilis was associated with IP/PP HIV MTCT (ARR, 2.74; 95% CI, 1.58-4.74), after adjusting for recent fever, breast infection, LBW and maternal log10 HIV-1 viral load. Maternal syphilis is associated with IU and IP/PP HIV MTCT. Screening and early treatment of maternal syphilis during pregnancy may reduce pediatric HIV infections.
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              Causes of false-positive HIV rapid diagnostic test results

              HIV rapid diagnostic tests have enabled widespread implementation of HIV programs in resource-limited settings. If the tests used in the diagnostic algorithm are susceptible to the same cause for false positivity, a false-positive diagnosis may result in devastating consequences. In resource-limited settings, the lack of routine confirmatory testing, compounded by incorrect interpretation of weak positive test lines and use of tie-breaker algorithms, can leave a false-positive diagnosis undetected. We propose that heightened CD5+ and early B-lymphocyte response polyclonal cross-reactivity are a major cause of HIV false positivity in certain settings; thus, test performance may vary significantly in different geographical areas and populations. There is an urgent need for policy makers to recognize that HIV rapid diagnostic tests are screening tests and mandate confirmatory testing before reporting an HIV-positive result. In addition, weak positive results should not be recognized as valid except in the screening of blood donors.
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                Author and article information

                Contributors
                avdheuvel@itg.be
                hsmet@itg.be
                Prati@who.int
                Sandsa@who.int
                Urassaw@who.int
                kfransen@itg.be
                tcrucitti@itg.be
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                3 January 2019
                3 January 2019
                2019
                : 19
                : 1
                Affiliations
                [1 ]ISNI 0000 0001 2153 5088, GRID grid.11505.30, HIV/STI Reference Laboratory, Department of Clinical Sciences, , Institute of Tropical Medicine, ; Antwerp, Belgium
                [2 ]ISNI 0000000121633745, GRID grid.3575.4, World Health Organisation (WHO), ; Geneva, Switzerland
                Article
                3567
                10.1186/s12879-018-3567-x
                6318958
                30606108
                1a612e45-b7f2-4c9d-9f16-575c2d27cacc
                © The Author(s). 2019

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 June 2018
                : 29 November 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004423, World Health Organization;
                Award ID: PO201153656
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2019

                Infectious disease & Microbiology
                Infectious disease & Microbiology

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